BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000

    MDR report key: 14190073 · Received April 22, 2022

    Report

    Report Number
    3016438761-2022-00173
    Event Type
    Malfunction
    Date Received
    April 22, 2022
    Date of Event
    March 14, 2022
    Report Date
    May 4, 2022
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740005924
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE INSTRUMENT AND RESOLVED THE ISSUE BY REPLACING THE ASPIRATE AND DISPENSE TUBING TO THE HIGH CONCENTRATION WASTE NOZZLE A (TBG. H.C. NOZZLE A WASTE (ROHS) AND TBG, H.C. NOZZLE A (ROHS)). NO ADDITIONAL DISCREPANT RESULT ISSUES HAVE BEEN REPORTED SINCE THE PARTS WERE REPLACED. THE INSTRUMENT SERVICE HISTORY REVIEW REVEALED TWO (2) ADDITIONAL SERVICE TICKETS THAT MAY BE RELATED TO THE CURRENT COMPLAINT. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS OR SYSTEMIC ISSUES FOR THE INSTRUMENT PARTS. A REVIEW OF THE PRODUCT MONITORING REVIEW FOR CLINICAL CHEMISTRY SYSTEMS DID NOT IDENTIFY ANY SIMILAR ISSUES RELATED TO THE ARCHITECT SYSTEM, LIKELY CAUSE PARTS, OR DISCREPANT RESULTS AS DESCRIBED IN THIS TICKET. THE ARCHITECT C4000, C8000, AND THE C16000 ERRATIC RESULT RATES WERE WITHIN ACCEPTABLE LIMITS WITH NO TRENDS IDENTIFIED. A REVIEW OF HISTORICAL DATA DID NOT IDENTIFY ANY NON-CONFORMANCES OR POTENTIAL NON-CONFORMANCES RELATED TO THE PARTS ASSOCIATED WITH THE COMPLAINT. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT C16000, SERIAL NUMBER (B)(6), WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER FOUND A LEAKAGE ON THE ARCHITECT C16000 PROCESSING MODULE THAT CAUSED THE TEST TO BE DILUTED DURING SAMPLE PROCESSING. THE CUSTOMER REPLACED 7-203008-01 TBG, HC NOZZLE A AND THEN 7-203008-02 TBG HC NOZZLE A. THE CUSTOMER RAN CONTROLS AND CHECKED THE LAST RELEASED RESULTS. EVERYTHING LOOKED OK, BUT THE CUSTOMER STATED THE DOCTOR HAD QUESTIONED PATIENT RESULTS SINCE THEY WERE NOT CONSISTENT WITH PATIENT HISTORY. THE CUSTOMER PROVIDED FALSELY ELEVATED CREATININE RESULTS FOR ONE PATIENT. SID (B)(6), (B)(6) 2022: CREAENZ = 579 UMOL/L, REPEAT ON (B)(6) 2022: CREAENZ = 50 UMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171223 ARCHITECT C16000 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 3L77-01 00380740005924

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CREATININE, UNKNOWN LIST AND LOT NUMBER| CREATININE, UNKNOWN LIST AND LOT NUMBER